Telemonitoring of Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incidence of death
研究概览
简要总结
The aim of this study is to find out whether remote health monitoring can help people with chronic heart failure.
For 3 months, some patients use a SiDLY CARE PRO electronic wristband. It measures their physical activity, blood oxygen level and heart rate every 15 minutes. The information is sent electronically to a secure database.
The study includes two groups of patients. One group uses the wristband and receives regular cardiology care. The other group receives regular care without remote monitoring.
During the study, patients have three visits at the cardiology clinic. Their health, heart failure symptoms and treatment are assessed. They also complete short questionnaires about their quality of life and ability to perform everyday activities. The researchers compare the two groups to see whether remote monitoring is associated with better health and fewer hospital stays or deaths related to worsening heart failure.
The study began in February 2023 and is planned to continue until 31 December 2028.
详细描述
The aim of this study is to observe the impact of the 3-month telemonitoring intervention using an electronic wristband measuring physical activity, peripheral capillary oxygen saturation and heart rate (HR) in the population of clinically stable patients with chronic heart failure with reduced ejection fraction (HFrEF), compared with the control group of patients not undergoing this intervention.
The participants are recruited in the Clinical Ward of Cardiology and the outpatient cardiology clinic of the Central Teaching Hospital of the Medical University of Lodz, Poland. During the preliminary phase of the study (Frebruary 2023-May 2024) patients were consecutively recruited to the study arm, followed by the recruitment of patients to the control arm.
During the first study visit, the patients in the intervention group received an electronic wearable wristband SiDLY CARE PRO, which monitored their physical activity, peripheral capillary oxygen saturation and heart rate, taking measurements at 15-minute intervals and transmitting the results to a database. All the participants from both the study and the control group received standard care at the cardiology clinic. The study period covered the following 3 months, during which each patient underwent 3 outpatient visits. During each visit, a physical examination was performed, the history of medical events, a potential exacerbation of heart failure and possible changes in pharmacotherapy was obtained, and the following patient's functional assessment scales were completed: the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), the Visual Analogue Scale (VAS) and the 6 Activities of Daily Living Scale (6ADL). At V1, the Timed Up and Go Test (TUG) was also performed.
In both groups participating in the study, the incidence of a composite endpoint defined as death or hospitalisation for acute decompensated heart failure, its two components separately, HF-related hospitalisation equivalents as well as selected physical parameters and the results of the validated questionnaires mentioned above were analysed. In the study group, the data obtained by the telemonitoring wristbands were also analysed in subgroups specified on the basis of the time since the initiation of the intervention, the results of the KCCQ-12 and the occurrence of a composite endpoint.
After the initial phase of the study and acquisition of preliminary results, the prolongation of the study is planned until the 31st of December 2028 using the same protocol as the initial phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provided written informed consent prior to any study specific procedures;
- •males and females aged >18 years old at the time of consent;
- •documented diagnosis of HFrEF prior to enrollment and optimally treated with pharmacological and/or device therapy;
- •left ventricular ejection fraction ≤40% in a transthoracic echocardiogram from the last 12 months before recruitment;
- •NYHA class II-III.
排除标准
- •acute or decompensated heart failure;
- •the primary cause of heart failure in the form of active myocarditis, constrictive pericarditis or a valvular heart disease that has not been treated by interventional or surgical means, as defined by the ESC guidelines;
- •myocardial infarction, unstable angina, stroke or transient ischemic attack, coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft, valve replacement surgery or ICD/CRT implantation within 4 weeks prior to study enrollment;
- •planned coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft;
- •planned valve replacement surgery;
- •status after heart transplantation;
- •symptomatic bradycardia or third-degree atrioventricular block without a pacemaker;
- •a severe non-cardiovascular disease with a life expectancy of less than 1 year, or a patient condition precluding the performance of the procedures specified in the study protocol;
- •diagnosis of malignancy at the time of screening;
- •history of an allergic reaction to materials contained in the wristband.
研究组 & 干预措施
Intervention (telemonitoring) group
At the first study visit the study group received an electronic wearable wristband SiDLY CARE PRO (SiDLY, Poland; medical device CE 0197 marking) measuring HR, peripheral capillary oxygen saturation and number of steps at 15-minute intervals. The data were transmitted remotely to an online database during the follow-up. The follow-up included three outpatient visits with a frequency of once every 30 ± 3 days. During the visits, the participants of the study group received standard care and feedback on the telemonitoring data.
干预措施: Telemonitoring wristband (Device)
Control group
The control group had the same number of follow-up visits during the study, but received no devices and thus, no feedback on telemonitoring data.
After the study enrollment, the follow-up included three outpatient visits with a frequency of once every 30 ± 3 days. During the visits, the participants of the control group received standard care.
结局指标
主要结局
The incidence of death
时间窗: From enrollment to the end of follow-up at 3 months
The incidence of death assessed in both study and control group
The incidence of hospitalisation for acute decompensated heart failure or its equivalent
时间窗: From enrollment to the end of follow-up at 3 months
The incidence of hospitalisation for acute decompensated heart failure or its equivalent will be assessed in both study and control arm. The equivalent of hospitalisation is defined as the need for intravenous diuretic therapy, intravenous catecholamine infusion or passive oxygen therapy.
次要结局
- The number of participants with jugular vein congestion(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants who needed an oral cardiac pharmacotherapy dose escalation(At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) outcomes(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants with lung crepitations(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants with pleural effusion(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants with peripheral edema(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants with hepatomegaly(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants with ascites(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants with orthopnea(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The number of participants who needed an oral diuretic initiation or dose escalation(At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The Visual Analogue Scale (VAS) outcomes(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The 6 Activities of Daily Living Scale (6ADL) outcomes(At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90))
- The Timed Up and Go Test (TUG) outcomes(At visit 1 (day 0))
研究者
Jaroslaw Drozdz
Professor, Head of the 2nd Department of Cardiology, Medical University of Lodz, Poland
Medical University of Lodz